Device product

Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927

Z-1472-2022

June 06, 2022

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - SPT
Event: Event 90516
Status: Ongoing
Classification: Class II
Quantity: 477 units
Official record key: device-enforcement:Z-1472-2022

Official wording

Reason: Kits contain leaking bottles of isopropyl alcohol

Code information: Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Kits contain leaking bottles of isopropyl alcohol